Electrocardiography

Electrocardiograms (ECG) are a primary cardiac diagnostic test that measures the electrical activity in heart to identify overall cardiac function, arrhythmias and areas of ischemia and infarct. Standard 12-lead ECG breaks the 3D structure of the heart into 12 zones, each showing the electrical activity in that specific area of the heart. This narrows down areas where there are issues with coronary artery disease or electrophysiology issues. Many ambulatory heart monitors and consumer-grade ECG monitors use fewer leads so are less specific as to cardiac conditions or location of abnormal heart rhythms, but can show an issue that requires further diagnostic testing or treatment.

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AliveCor, a California-based healthcare company focused on developing on-the-go electrocardiography (ECG) devices, has gained U.S. Food and Drug Administration (FDA) clearance for its KAI 12L artificial intelligence (AI) technology and the new handheld Kardia 12L ECG System.

Dual approvals: AliveCor gains FDA clearance for advanced AI model, handheld ECG system

One of the company's new approvals was for a pocket-sized ECG system designed to be less invasive and easier to use than other devices on the market. 

How long do wearable cardiac monitors record data?

Long-term continuous monitoring (LTCM) wearable devices now make up 40% or more of the remote ECG monitoring market due to ease of use and collection of more data.

Video interview with Matthew Reynolds, MD, who shares data on largest wearable ambulatory cardiac monitoring studies to date from the EXCALIBER and CAMELOT trials at HRS 2024. #HRS #HRS2024 #Remotemonitoring

First large-scale studies of wearable ambulatory cardiac monitoring shed light on usage 

Matthew Reynolds, MD, Lahey Hospital and Medical Center, explains data from the EXCALIBER and CAMELOT studies that show ambulatory cardiac monitoring usage among more than 300,000 patients.

The central illustration from a study that shows the impact of ECG AI algorithm study case and control selection to train artificial intelligence to better screening patients for cardiac amyloidosis. Image courtesy of JACC Advances.

Using ECG AI to find the cardiac amyloidosis needles in the haystack

Early detection of cardiac amyloidosis is leads to the best outcomes, but it is often missed until later stages. AI is being developed to help detect these patients earlier using ECG and echo.

The U.S. Food and Drug Administration (FDA) announced that Vyaire Medical has recalled the twin tube samples lines from its Vyntus CPX Metabolic Cart due to ongoing safety concerns. This is a Class I recall, which means the FDA believes using these devices “may cause serious injuries or death.”

FDA announces new Class I recall of CPET devices due to choking hazard

If left unchecked, the devices could put patients at risk of serious injuries or death as they undergo cardiopulmonary evaluations. 

WearLinq's eWave six-lead wearable ECG monitor

Wearable ECG specialists acquire new testing facility to reach more patients

San Francisco-based WearLinq says the acquisition will help its six-lead ECG technology reach more heart patients throughout the United States.   

Cardiology ranked No. 2 among all specialties with 122 FDA-cleared AI models

Only radiology is associated with more FDA-cleared AI algorithms than cardiology, according to new federal data. 

JR Finkelmeier PaceMate

PaceMate names former Philips, BioTelemetry leader its new chief commercial officer

JR Finkelmeier has more than 20 years of experience in the healthcare and medical device industries.

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